Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma (PD-L1)

Bristol-Myers Squibb (BMS)

Status and phase

Withdrawn

Phase 1

Conditions

Stage III or IV Melanoma

Treatments

Biological: BMS-936559 (Anti-PD-L1)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01455103

CA210-002

Details and patient eligibility

About

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) status = 0 to 1
Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma
Subject must have histologic or cytologic confirmation of advanced Melanoma
Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies

Exclusion criteria

Active or progressing brain metastases
Other concomitant malignancies (with some exceptions per protocol)
Active or history of autoimmune disease
Positive test for human immunodeficiency virus (HIV) 1&2 or known acquired immunodeficiency syndrome (AIDS)
History of any hepatitis
Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies